Heart Failure Catheter Met Study Safety Goals
A new device designed to improve kidney function in heart failure patients successfully completed its feasibility study.
Updated on Oct. 10, 2026 in Heart Disease
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The DORAYA-HF feasibility study successfully tested a new percutaneous catheter designed to assist with fluid management in patients with heart failure. The device showed promise in early testing across 16 participants in the United States.
Why it matters
Congestion is a major challenge for heart failure patients, and this catheter aims to relieve it by reducing pressure in the renal venous system. This approach may provide a new way to help manage fluid overload and improve kidney output in clinical settings.
In a 16-patient feasibility study conducted at 6 US sites between 2022 and 2024, the Doraya catheter was successfully implanted in all participants. Researchers observed an increase in urine output from 80 mL/hour at baseline to 224.1 mL/hour while the device was in place.
The players
Heart Failure Society of America
A professional organization dedicated to the research and management of heart failure that hosted the recent presentation of these study results.
The details
The Doraya device is placed transfemorally into the inferior vena cava and remains in the body for 12 hours or less. Its distal frame opening creates a partial obstruction of venous flow, which helps reduce cardiac preload. By lowering pressure in the renal venous system, the device facilitates improved decongestion and urine production.
Timeline
The DORAYA-HF feasibility study enrolled participants between 2022 and 2024.
Data from the study were presented at the HFSA Annual Scientific Meeting on October 9-12, 2026.
A larger, pivotal clinical trial for the catheter is expected to begin in early 2027.
Health Landscape
This development represents an exploratory step in the evolution of catheter-based interventions for heart failure management. It aligns with ongoing efforts to reduce patient readmissions by targeting renal venous pressure.
This study is an early-stage result and does not change current treatment protocols for heart failure. Patients should continue to follow their existing management plans and discuss any new technology updates with their cardiologist.
The takeaway
The Doraya catheter has shown a potential mechanical approach to improving fluid decongestion in small-scale human testing. Patients managing heart failure should continue to track their fluid intake and weight as directed by their doctor to manage congestion.
What happens next
A larger, pivotal clinical trial for the Doraya catheter is currently scheduled to begin in early 2027.
Further reading
For more information on current management strategies, visit our Heart Disease section.
More information
Review the full details of the DORAYA-HF clinical trial information on the official registry.
Source note: This article includes information reported by Hcplive.
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Would you feel comfortable using a new, minimally invasive device to treat chronic heart failure?
